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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.10398

摘要内容如下：

重要性

尽管有证据表明早期姑息治疗可以改善结果，但由于姑息治疗劳动力的限制，早期姑息治疗尚未得到广泛实施。

目的

评估阶梯式护理模式，为晚期癌症患者提供更少的资源密集和更多的以患者为中心的姑息治疗。

设计、设置和参与者

2018年2月12日至2022年12月15日，在马萨诸塞州波士顿、宾夕法尼亚州费城和北卡罗来纳州达勒姆的3个学术医疗中心，对507名在过去12周内被诊断为晚期肺癌的患者进行了随机、非盲、非劣效性的阶梯式姑息治疗与早期姑息治疗试验。

干预

干预的第1步是在登记后4周内进行首次姑息治疗访视，随后仅在改变癌症治疗或住院后进行访视。在步骤1中，患者完成了生活质量（QOL；癌症治疗功能评估-肺[FACT-L]；范围0-136，得分越高表明生活质量越好），每6周一次，那些从基线下降10分或更多的患者每4周一次与姑息治疗临床医生会面（干预步骤2）。接受早期姑息治疗的患者在入组后每4周接受一次姑息治疗。

主要成果和措施

在第24周的FACT-L上，阶梯式姑息治疗与早期姑息治疗对患者报告的生活质量的影响的非劣效性（Margin=-4.5）。

结果

样本（n=507）主要包括晚期非小细胞肺癌患者（78.3%；平均年龄66.5岁；女性占51.4%；白人占84.6%）。到第24周，阶梯式姑息治疗的平均姑息治疗就诊次数为2.4，早期姑息治疗的平均姑息治疗就诊次数为4.7（调整后的平均差异为-2.3；P<.001）。在第24周，阶梯式姑息护理组的FACT-L评分并不劣于接受早期姑息护理的患者（调整后的FACT-L平均评分分别为100.6和97.8；差值，2.9；单侧95%置信下限，-0.1；非劣效性P<.001）。尽管两组之间的临终关怀沟通率也不差，但在临终关怀的天数中并未表现出非劣效性（校正平均值，阶梯式姑息治疗为19.5天，早期姑息治疗为34.6天；P=.91）。

结论和相关性

一种阶梯式护理模式，即姑息治疗就诊仅发生在患者癌症轨迹的关键点，并使用生活质量的降低来触发更多的强化姑息治疗暴露，导致姑息治疗就诊减少，而不会减少对患者生活质量的益处。虽然阶梯式姑息治疗与较少的临终关怀天数有关，但它是一种更具可扩展性的方式来提供早期姑息治疗，以提高患者报告的结果。

试用注册

ClinicalTrials.gov标识符：NCT03337399。

英文原文如下：

Abstracts

Importance  Despite the evidence for early palliative care improving outcomes, it has not been widely implemented in part due to palliative care workforce limitations.

Objective  To evaluate a stepped-care model to deliver less resource-intensive and more patient-centered palliative care for patients with advanced cancer.

Design, Setting, and Participants  Randomized, nonblinded, noninferiority trial of stepped vs early palliative care conducted between February 12, 2018, and December 15, 2022, at 3 academic medical centers in Boston, Massachusetts, Philadelphia, Pennsylvania, and Durham, North Carolina, among 507 patients who had been diagnosed with advanced lung cancer within the past 12 weeks.

Intervention  Step 1 of the intervention was an initial palliative care visit within 4 weeks of enrollment and subsequent visits only at the time of a change in cancer treatment or after a hospitalization. During step 1, patients completed a measure of quality of life (QOL; Functional Assessment of Cancer Therapy-Lung [FACT-L]; range, 0-136, with higher scores indicating better QOL) every 6 weeks, and those with a 10-point or greater decrease from baseline were stepped up to meet with the palliative care clinician every 4 weeks (intervention step 2). Patients assigned to early palliative care had palliative care visits every 4 weeks after enrollment.

Main Outcomes and Measures  Noninferiority (margin = -4.5) of the effect of stepped vs early palliative care on patient-reported QOL on the FACT-L at week 24.

Results  The sample (n = 507) mostly included patients with advanced non-small cell lung cancer (78.3%; mean age, 66.5 years; 51.4% female; 84.6% White). The mean number of palliative care visits by week 24 was 2.4 for stepped palliative care and 4.7 for early palliative care (adjusted mean difference, -2.3; P < .001). FACT-L scores at week 24 for the stepped palliative care group were noninferior to scores among those receiving early palliative care (adjusted FACT-L mean score, 100.6 vs 97.8, respectively; difference, 2.9; lower 1-sided 95% confidence limit, -0.1; P < .001 for noninferiority). Although the rate of end-of-life care communication was also noninferior between groups, noninferiority was not demonstrated for days in hospice (adjusted mean, 19.5 with stepped palliative care vs 34.6 with early palliative care; P = .91).

Conclusions and Relevance  A stepped-care model, with palliative care visits occurring only at key points in patients' cancer trajectories and using a decrement in QOL to trigger more intensive palliative care exposure, resulted in fewer palliative care visits without diminishing the benefits for patients' QOL. While stepped palliative care was associated with fewer days in hospice, it is a more scalable way to deliver early palliative care to enhance patient-reported outcomes.

Trial Registration  ClinicalTrials.gov Identifier: NCT03337399.

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